AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast (AuraGen)

Sientra

Status: Active, not recruiting

Conditions: Breast Fat Grafting Retention

Treatments: Device: AuraGen 1-2-3 with AuraClens

Study type: Interventional

Funder types: Industry

Identifiers

NCT05258305

AUG-002

Details and patient eligibility

About

Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.

Full description

Autologous fat transfer (AFT) is a medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen1-2-3 with AuraClens Lipoaspirate Wash System is designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister. The study population will consist of up to 200 subjects in (2) cohorts: 100 subjects undergoing breast reconstruction and 100 subjects undergoing breast augmentation. All subjects will receive autologous lipoaspirate processed with the A123+ AuraClens and will be followed post-procedure at 1-, 3-, 6-, and 12-months. Fat graft retention will be evaluated with 3D imaging using the Canfield Vectra XT imaging system. Patient satisfaction will be measured between baseline and the post-procedure follow-up visits using a breast satisfaction questionnaire.

Enrollment: 200 estimated patients

Sex: Female

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Augmentation Subjects

Inclusion Criteria:

• Female patients > 22 years and < 65 years of age.
• Patients with a BMI < 35.
• Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant.
• Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
• Patients must be non-smokers.
• Patients with available/adequate harvest sites for fat grafting.
• Anticipated harvested fat volume between 200 and 700 cc.
• Anticipated fat injection volume between 50 and 350 cc per breast.
• Anticipated breast implant volume between 200 and 550 cc.
• Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.

Exclusion Criteria:

• Skin rash in the treatment area.
• Patients who smoke or use nicotine products.
• Patients with bleeding disorders or currently taking anticoagulants.
• Patients with history of trauma or surgery to the treatment area.
• Patients with history of breast cancer.
• Active, chronic, or recurrent infection.
• Compromised immune system.
• Hypersensitivity to analgesic agents.
• Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
• Untreated drug and/or alcohol abuse.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.
• Patients who do not wish to have the study area (breast) photographed.

Reconstruction Subjects

Inclusion Criteria:

• Female patients > 18 years and < 65 years of age.
• Patients with a BMI < 35.
• Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant.
• Patient is at least 1 year post-completion of chemotherapy.
• Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
• Patients must be non-smokers.
• Patients with available/adequate harvest sites for fat grafting.
• Anticipated harvested fat volume between 200 and 700 cc.
• Anticipated fat injection volume between 50 nd 350cc per breast.
• Anticipated breast implant volume (if applicable) between 200 and 550 cc.
• Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.

Exclusion Criteria:

• Skin rash in the treatment area.
• Patients who smoke or use nicotine products.
• Patients with bleeding disorders or currently taking anticoagulants.
• Patients undergoing active treatment for breast cancer.
• Active, chronic, or recurrent infection.
• Compromised immune system.
• Hypersensitivity to analgesic agents.
• Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
• Untreated drug and/or alcohol abuse.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.
• Patients who do not wish to have the study area (breast) photographed.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Augmentation

Other group

Description:

Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.

Treatment:

Device: AuraGen 1-2-3 with AuraClens

Reconstruction

Other group

Description:

Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.

Treatment:

Device: AuraGen 1-2-3 with AuraClens